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NCT02281500 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia
A Phase 1 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02281500: Completed Phase 1 study, sponsored by Grifols Therapeutics.
NCT02281500 is a Phase 1 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02281500, a Phase 1 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.
Primary Outcome
AUC(0-14days) was calculated by a combination of linear and logarithmic trapezoidal methods and expressed in the unit of concentration × time. The linear trapezoidal method used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method used for those arising from decreasing concentrations. Plasma fibrinogen activity determined by the Clauss method in the central laboratory of the study. Pharmacokinetic (PK) parameters adjusted for baseline fibri
Interventions
- BIOLOGICAL Human Plasma-Derived Fibrinogen Concentrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-07-22 |
| Est. Completion | 2019-11-11 |
| Phase | Phase 1 |
What the finished NCT02281500 record still lists
NCT02281500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Human Plasma-Derived Fibrinogen Concentrate is the first listed.
NCT02281500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02281500 about?
NCT02281500 is a clinical study titled "Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia". The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.
What is the current status of trial NCT02281500?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-07-22. Estimated completion is 2019-11-11.
What interventions are being tested in trial NCT02281500?
The interventions under investigation include: Human Plasma-Derived Fibrinogen Concentrate (BIOLOGICAL).
Who is sponsoring clinical trial NCT02281500?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02281500's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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